wqatsqatalk.blogspot.com
WQATS - QA TALK: January 2009
http://wqatsqatalk.blogspot.com/2009_01_01_archive.html
WQATS - QA TALK. Wednesday, January 28, 2009. Writing SOPs - Part 4. Now, BACK TO WRITING SOPS! Next time, we will discuss the finalization process! Have a QUALITY day! Sarah Wilson, BS, MS,CCRP. Links to this post. Labels: clinical research associate. Writing standard operating procedures. Friday, January 16, 2009. QA-Talk: Writing SOPs - Part 3. At this point, you should have completed Parts 1 and 2 of Writing SOPs. If you haven't, you can find them here. Search my blog. Have a QUALITY day! In our last...
wqatsqatalk.blogspot.com
WQATS - QA TALK: Why I Love Auditing - True Stories to Make You Smile
http://wqatsqatalk.blogspot.com/2010/01/why-i-love-auditing-true-stories-to.html
WQATS - QA TALK. Sunday, January 3, 2010. Why I Love Auditing - True Stories to Make You Smile. People often say I should write a book. I doubt if I ever will, but I (in many cases along with my colleagues) have experienced some real interesting audits. I will tell you in advance that all of these tales are true. I will also tell you that any names used (other than mine) have been changed to protect the innocent - yes, some of them really were innocent. In a clinical trial and when the subject returned t...
wqatsqatalk.blogspot.com
WQATS - QA TALK: Part 6: Tracking Standard Operating Procedures: Excel Spreadsheet or Document Software?
http://wqatsqatalk.blogspot.com/2009/07/part-6-tracking-standard-operating.html
WQATS - QA TALK. Thursday, July 9, 2009. Part 6: Tracking Standard Operating Procedures: Excel Spreadsheet or Document Software? Now that you have created your SOPs, you (QA mostly) must track them and monitor them to verify that they are 1)current and 2) being used as written. First - for tracking purposes - you should have the following headings:. Date Submitted for Review. With the software, you will be able to document the history of each SOP and then when the company is inspected (it is never IF.
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WQATS - QA TALK: August 2008
http://wqatsqatalk.blogspot.com/2008_08_01_archive.html
WQATS - QA TALK. Saturday, August 9, 2008. As the unemployment rate in America continue to rise, professionals are exploring opportunities to gain an edge in the interview arena. I'm glad to see this because that means more professionals are realizing the importance of certifications, training and experience. These items are extremely important and the competition out there is fierce! There are a lot of jobs availble in the UK for CRAs. Do you know enough about clinical trials in the UK to work there?
wqatsqatalk.blogspot.com
WQATS - QA TALK: April 2009
http://wqatsqatalk.blogspot.com/2009_04_01_archive.html
WQATS - QA TALK. Wednesday, April 15, 2009. Finalizing Standard Operating Procedures (SOPs) - PART 5. Alright. I'm back and we're going to cover the next most important step to getting Standard Operating Procedures up and running at your company or site. Wide open for tips on non-compliance. When you hear it, research it and jump on it before that molehill becomes a mountain. Once you get the managers to agree on the wording, quickly close the meeting and "WALK" that SOP around that day for signatures.
wqatsqatalk.blogspot.com
WQATS - QA TALK: Finalizing Standard Operating Procedures (SOPs) - PART 5
http://wqatsqatalk.blogspot.com/2009/04/finalizing-standard-operating.html
WQATS - QA TALK. Wednesday, April 15, 2009. Finalizing Standard Operating Procedures (SOPs) - PART 5. Alright. I'm back and we're going to cover the next most important step to getting Standard Operating Procedures up and running at your company or site. Wide open for tips on non-compliance. When you hear it, research it and jump on it before that molehill becomes a mountain. Once you get the managers to agree on the wording, quickly close the meeting and "WALK" that SOP around that day for signatures.
wqatsqatalk.blogspot.com
WQATS - QA TALK: Writing SOPs - Part 1
http://wqatsqatalk.blogspot.com/2009/01/writing-sops-part-1.html
WQATS - QA TALK. Sunday, January 11, 2009. Writing SOPs - Part 1. The first thing you want to do when writing a SOP is identify the person who knows the most about the job. For example, if you need an SOP on how to enter data into SAS, then choose this person who actually performs the task to write the SOP. The first think you need is wordprocessing software such as Word, Works or OpenOffice. Have a Quality day! For more about me, visit www.wqats.com. Sarah Wilson, BS, MS,CCRP. How to Avoid Social Kisses.
wqatsqatalk.blogspot.com
WQATS - QA TALK: Writing SOPs - Part 2
http://wqatsqatalk.blogspot.com/2009/01/writing-sops-part-2.html
WQATS - QA TALK. Tuesday, January 13, 2009. Writing SOPs - Part 2. In our last session, we created the first part of the SOP, which was the header. (See Part 1 if you haven't done that part yet). Today we are going to start on the 2nd major section of the SOP. This section consists of the Purpose, Scope, Background, Defintions and Abbreviations, and applicable Attachments. Under the heading " Purpose. The next paragraph in this section will be the SOP's " Scope. Will be templates or diagrams used to guid...
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WQATS - QA TALK: June 2008
http://wqatsqatalk.blogspot.com/2008_06_01_archive.html
WQATS - QA TALK. Monday, June 23, 2008. QA Talk Research Misconduct - Part II. As previously mentioned I've been involved with overseeing corrective action for three research misconduct sites. I'm going to back it up a a little and talk about how research misconduct was discovered. The first case of research. Misconduct I investigated occurred when a Clinical Research Coordinator ( CRC. Decided to throw away the investigational. Found this purely by accident. During a monitoring visit the CRA. She said s...
wqatsqatalk.blogspot.com
WQATS - QA TALK: January 2010
http://wqatsqatalk.blogspot.com/2010_01_01_archive.html
WQATS - QA TALK. Sunday, January 3, 2010. Why I Love Auditing - True Stories to Make You Smile. People often say I should write a book. I doubt if I ever will, but I (in many cases along with my colleagues) have experienced some real interesting audits. I will tell you in advance that all of these tales are true. I will also tell you that any names used (other than mine) have been changed to protect the innocent - yes, some of them really were innocent. In a clinical trial and when the subject returned t...
